Important Safety Information

VenaSeal™ Closure System

Intended Use/Indications:

The VenaSeal™ closure system (VenaSeal™ system) is indicated for use in the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. The VenaSeal system is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).

Contraindications:

Separate use of the individual components of the VenaSeal Closure System is contraindicated. These components must be used a system. The use of the VenaSeal™ system is contraindicated when any of the following conditions exist:

previous hypersensitivity reactions to the VenaSeal adhesive or cyanoacrylates,

acute superficial thrombophlebitis,

thrombophlebitis migrans,

acute sepsis exists.

Warnings:

The VenaSeal™ system should only be used by a trained physician with experience in diagnosis and treatment of venous reflux disease through endovenous techniques. Physicians require training using the VenaSeal system by the manufacturer prior to performing this procedure independently.

Due to the risk of exposure to HIV or other blood borne pathogens, health care workers should always use standard blood and body fluid precautions in the care of all patients. Sterile techniques should be strictly adhered to during any handling of the device.

The VenaSeal system is not designed for use in the coronary and cerebral vasculature, pulmonary vasculature, diseased and atherosclerotic arteries.

Do not flush the catheter with saline or fluid as this will make it unusable with the VenaSeal™ adhesive.

Manipulate the catheter ONLY under ultrasound imaging guidance.

Confirm position of the catheter tip in the desired location by ultrasound imaging before activation of the device.

Injection of the VenaSeal adhesive should be done by hand injection only and using the VenaSeal™ delivery system provided. Do not use a power injector.

Do not kink the catheter. Do not use the catheter if kinked.

Use the introducer in the VenaSeal delivery system for access to the peripheral vasculature. Failure to use the introducer for access may result in damage to the vessel, or failure of the VenaSeal system to perform as intended.

Precautions:

The safety and effectiveness of the VenaSeal™ system in pregnant women and in pediatric patients have not been established.

The VenaSeal system is sterile unless the package is opened or damaged. The package should be examined prior to use. If the package is damaged DO NOT USE.

The VenaSeal system is intended for single patient use only. DO NOT REUSE or RE-STERILIZE.

Prior to use, carefully examine the VenaSeal system components and verify they, and their packaging, have not been damaged during shipment. If the components show any sign of damage DO NOT USE.

Do not use after the expiration date.

Verify that the VenaSeal™ adhesive is a clear and free-flowing liquid prior to use. Material that is discolored should be discarded.

The VenaSeal adhesive will adhere to most surfaces. Avoid contact with non-disposable surfaces.

Gloves and eye/face protection are recommended when handling the VenaSeal adhesive.

The VenaSeal adhesive is intended to be delivered via the VenaSeal™ delivery system components only

Potential Adverse Effects of the Device on Health:

Below is a list of the potential adverse effects (e.g., complications) associated with the use of the VenaSeal™ system. The adverse events associated with the device are similar to those with traditional endovenous thermal ablation procedures. In addition, there are several risks unique to the VenaSeal system due to its material and product design as an implant. These potential adverse events include, but are not limited to, the following:

Allergic reactions to cyanoacrylates, such as hives, asthma, hay fever and anaphylactic shock

Arteriovenous fistula

Bleeding from the site of access

Deep vein thrombosis (DVT)

Edema in the treated leg

Embolization, including pulmonary embolism (PE)

Hematoma

Hyperpigmentation

Infection at the access site

Non-specific mild inflammation of the cutaneous and subcutaneous tissue